ATUSA 3D automated breast ultrasound for suspicious breast lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

AUDIBLE is a multi-site observational registry in the United States collecting 3D automated breast ultrasound images using the iSono Health ATUSA system from up to 800 female patients with BI-RADS 4 or 5 findings referred for biopsy. Participants will undergo ATUSA imaging in addition to their standard-of-care imaging and the study will gather multi-modality images, medical record data, and biopsy histopathology. The protocol examines image quality, reproducibility, and how ATUSA findings correlate with radiologist-assigned BI-RADS categories and histopathology, and follows a subset of patients receiving neoadjuvant therapy longitudinally. Collected data will be centralized to support device validation and a comprehensive imaging registry.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provide written informed consent through a signed and dated consent form.
2. Demonstrate commitment to complete all study requirements and maintain availability for the full study duration.
3. Be female, aged 18 to 94 years (inclusive).
4. Have a recent BI-RADS® 4 or 5 classification confirmed through breast imaging and medical records.

Exclusion Criteria:

1. Active skin lesions (open wounds or unhealed sores) on either breast.
2. Implanted medical devices (pacemakers, defibrillators) or MRI incompatible materials that cannot be temporarily removed.
3. Current pregnancy or breastfeeding status (self-reported).Documented hypersensitivity to silicone or gadolinium-based contrast agents.
4. Previous bilateral mastectomy.
5. Physical inability to maintain a supine position for 30 minutes.
6. Breast anatomy incompatible with ATUSA device specifications.
7. Recent (within 12 months) breast surgery or cancer treatment.
8. Negative findings on diagnostic ultrasound examination within 30 days of Screening, but prior to initiating study required procedures.
9. Any medical or psychological condition that, in the Principal Investigator's judgment, could affect study participation or data integrity.

Where it's running

• UC Davis
  Sacramento, California, United States Recruiting
• Cypress Innovative Breast Care Center
  Cypress, Texas, United States Recruiting

Study contacts

• Study coordinator: Neda Razavi
• Email: ATUSA@isonohealth.com
• Phone: 415-857-3073

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.